Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

• Pharmacovigilance
• Pharmacovigilance in India
• ADR reporting Procedure
• How to Fill ADR form
• Causality Assessment

• Insufficient evidence from preclinical and clinical studies
• Dying from disease unavoidable, dying from Medicine Unacceptable
• ADRs are expensive
• Promotion of rational use of medicine
• Ensuring public confidence
• Ethical Aspects

• 1986 – ADR Monitoring for India proposed with 12 regional centres
• 1997 – India Joined WHO ADR monitoring programme
• 2004-2008 – National Pharmacovigilance programme
• 2010- Pharmacovigilance programme of India

• Improve patient care and safety
• Improve public health and safety
• Early detection of unknown safety problems
• Identification of risk factors
• Quantifying risks
• Assessment of benefit, harm and effectiveness
• Encouraging safe, rational and effective use
• Promote understanding, education and clinical training in pharmacovigilance

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